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Идёт набор NCT06837103

Real-world Effects of Using Intermittently Scanned Continuous Glucose Monitoring and Pharmacist-led Coaching on the Management of Type 2 Diabetes Among Adults Not Using Insulin (REAL isCGM T2D)

— Наблюдательное Type 2 Diabetes

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Intermittently Scanned Continuous Glucose Monitor.
Кому может быть актуально
Состояния в реестре: Type 2 Diabetes. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
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Официальное название

Real-world Effects of Using Intermittently Scanned Continuous Glucose Monitoring and Pharmacist-led Coaching on the Management of Type 2 Diabetes Among Adults Using Non-insulin Antihyperglycemic Agents

Обзор

The goal of this prospective study is to evaluate diabetes outcomes after initiating second generation intermittently scanned continuous glucose monitoring (isCGM) plus one pharmacist consultation session compared with capillary blood glucose (CBG) monitoring among insulin-naïve adults with type 2 diabetes (T2D) in a specialist endocrinology clinical setting in Canada. Primary Outcome - To evaluate change in HbA1c at 3-6 months follow-up after initiating isCGM plus one pharmacist consultation (isCGM cohort) compared with CBG monitoring (CBG cohort) among insulin-naïve adults with T2D. Secondary Outcomes - To determine the change in metabolic outcomes and patient reported outcomes (PROs) and number of non-insulin antihyperglycemic agents (AHAs) prescribed from baseline to 3-6 months (± 6 weeks) in the isCGM cohort compared to the CBG cohort. Another secondary outcome is to assess isCGM metrics and number of isCGM discontinuations in the isCGM cohort at 3-6 months (± 6 weeks) compared to baseline. Additionally the study will describe and/or evaluate glycemic and metabolic outcomes, and PROs in participants who initiate an isCGM device and opt to enroll in a diabetes coaching program (isCGM+coaching cohort) at baseline compared to follow-up at 3-6 months (± 6 weeks). Exploratory Outcomes - To compare change in HbA1c between the matched isCGM cohort and CBG cohort by subgroups: age (\< 65 years old vs ≥ 65 years old) and baseline HbA1c (\< 8.5% vs ≥ 8.5%).

Вмешательства

  • Устройство Intermittently Scanned Continuous Glucose Monitor
    intervention used by the isCGM and isCGM+Coaching groups

Первичные конечные точки

  • Change in HbA1c [Срок оценки: from enrollment to 3-6 month follow up]
Вторичные конечные точки (12)
  • Change in Weight [Срок оценки: from enrollment to 3-6 month follow up]
  • Change in BMI [Срок оценки: from enrollment to 3-6 month follow up]
  • Change in Blood Pressure [Срок оценки: from enrollment to 3-6 month follow up]
  • Proportion of Participants Achieving HbA1c ≤ 7.0% at Follow-Up [Срок оценки: from enrollment to 3-6 month follow up]
  • Proportion of Participants with ≥1 Self-Reported Hypoglycemic Event per Week [Срок оценки: from enrollment to 3-6 month follow up]
  • Percent Time in Range (TIR) [Срок оценки: from enrollment to 3-6 month follow up]
  • Percent Time Below Range (TBR) [Срок оценки: from enrollment to 3-6 month follow up]
  • Percent Time Below Range (TBR) in Level 2 Hypoglycemia [Срок оценки: from enrollment to 3-6 month follow up]
  • Percent Time Above Range (TAR) [Срок оценки: from enrollment to 3-6 month follow up]
  • Estimated Glucose Management Indicator (eGMI) [Срок оценки: from enrollment to 3-6 month follow up]
  • Mean glucose [Срок оценки: from enrollment to 3-6 month follow up]
  • Glycemic variability [Срок оценки: from enrollment to 3-6 month follow up]

Критерии участия

Критерии включения

  • 18 years or older
  • Clinical diagnosis of T2D ≥ one year
  • Using at least one AHA
  • Status as a Sun Life group benefits member, initiates isCGM device through Lumino Health™ Pharmacy, and completes one initial pharmacist consultation (isCGM cohort) or completes 2 or more diabetes coaching program consultations (isCGM+coaching cohort); or has private health insurance and uses CBG monitoring (CBG cohort)
  • Baseline HbA1c ≥ 7.0%
  • ≥ 1 HbA1c value up to 6 months prior to index date
  • Exclusive use of isCGM for ≥ 3 months
  • Informed consent

Критерии исключения

  • Have a history of insulin use
  • Are pregnant or breastfeeding at the time of study enrollment or become pregnant during the study
  • Have an estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2
  • Previously used rtCGM or isCGM for > 3 months
  • Recent or expectant change to antihyperglycemic medications or doses within 30 days of index date

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Канада · 1 центр
  • LMC Diabetes & Endocrinology Ltd. — Toronto

Идентификаторы

NCT: NCT06837103 · REAL isCGM T2D

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗